Russia's race for virus vaccine raises concerns in the West

Russia boasts that it's about to become first country to approve a COVID-19 vaccine, with mass vaccinations planned as early as October using shots that are yet to complete clinical trials -- and scientists worldwide are sounding alarm that helong rush could backfire.

Moscow sees a Sputnik-like propaganda victory, recalling Soviet Union's launch of world's first satellite in 1957. But experimental COVID-19 shots began first-in-human testing on a few dozen people less than two months ago, and re's published scientific evidence yet backing Russia's late entry to global vaccine race, much less explaining why it should be considered a front-runner.

“I'm worried that Russia is cutting corners so that vaccine that will come out may be t just ineffective, but also unsafe,” said Lawrence Gostin, a global public health law expert at Georgetown University.

“It doesn't work that way... Trials come first. That's really important.”

According to Kirill Dmitriev, he of Russia's Direct Investment Fund that bankrolled effort, a vaccine developed by Gamaleya research institute in Moscow may be approved in days, before scientists complete what's called a Phase 3 study. That final-st study, usually involving tens of thousands of people, is only way to prove if an experimental vaccine is safe and really works.

Health Minister Mikhail Murashko said members of “risk groups,” such as medical workers, may be offered vaccine this month. He didn't clarify wher y would be part of Phase 3 study that is said to be completed after vaccine receives “conditional approval.” Deputy Prime Minister Tatyana Golikova promised to start “industrial production” in September, and Murashko said mass vaccination may begin as early as October. Dr Anthony Fauci, top US infectious disease specialist, questioned fast-track approach last week.

“I do hope that Chinese and Russians are actually testing a vaccine before y are ministering vaccine to anyone, because claims of having a vaccine rey to distribute before you do testing I think is problematic at best," he said.

Questions about this vaccine candidate come after U.S., Britain and Cana last month accused Russia of using hackers to steal vaccine research from Western labs. Delivering a vaccine first is a matter of national prestige for Kremlin as it tries to assert im of Russia as a global power capable of competing with US and China.

tion of being “ first in world” dominated state news cover of effort, with government officials praising reports of first-step testing. In April, President Vlimir Putin ordered state officials to shorten time of clinical trials for a variety of drugs, including potential coronavirus vaccines.

According to Russia's Association of Clinical Trials Organizations, order set “an unattainable bar” for scientists who, as a result, "joined in on m race, hoping to please those at power.” association first raised concern in late May, when professor Alexander Gintsburg, he of Gamaleya institute, said he and or researchers tried vaccine on mselves.

move was a “crude violation of very foundations of clinical research, Russian law and universally accepted international regulations" group said in an open letter to government, urging scientists and health officials to here to clinical research standards.

But a month later, Health Ministry authorized clinical trials of Gamaleya product, with what appeared to be ar ethical issue. Human studies started June 17 among 76 volunteers. Half were injected with a vaccine in liquid form and or half with a vaccine that came as soluble powder. Some in first half were recruited from military, which raised concerns that servicemen may have been pressured to participate.

Some experts said ir desire to perform well would affect findings. “It's coincidence media reports we see about trials among military said one h any side effects, while (or group) reported some," said Vasily Vlassov, a public health expert with Moscow's Higher School of Ecomics.

As trials were declared completed and looming regulatory approval was anunced last week, questions arose about vaccine's safety and effectiveness. Government assurances drug produced desired immune response and caused significant side effects were hardly convincing without published scientific data describing findings. World Health Organization said all vaccine candidates should go through full sts of testing before being rolled out.

“re are established practices and re are guidelines out,” WHO spokesman Christian Lindmeier said Tuesday.

“Between finding or having a clue of maybe having a vaccine that works, and having gone through all sts, is a big difference.”

Offering an unsafe compound to medical workers on front lines of outbreak could make things worse, Georgetown's Gostin said, ding:

“What if vaccine started killing m or making m very ill?”

Vaccines that are t properly tested can cause harm in many ways from a negative impact on health to creating a false sense of security or undermining trust in vaccinations, said Thomas Bollyky, director of global health program at Council on Foreign Relations.